U.S. patent number 4,518,565 [Application Number 06/501,609] was granted by the patent office on 1985-05-21 for reagent test device holder.
This patent grant is currently assigned to Miles Laboratories, Inc.. Invention is credited to David L. Boger, Jerry T. Pugh, Jack Zuidema.
United States Patent |
4,518,565 |
Boger , et al. |
May 21, 1985 |
Reagent test device holder
Abstract
Apparatus for accurately positioning and retaining multiple,
individual reagent test devices in a holder. The holder consists of
a base member and a top member in which the top member contains
openings of at least the same number and dimension as the reagent
pads appearing on the test devices. The holder permits the
practical utilization of multiple, individual dip-and-read test
devices in automated instrumentation.
Inventors: |
Boger; David L. (South Bend,
IN), Pugh; Jerry T. (Elkhart, IN), Zuidema; Jack
(Elkhart, IN) |
Assignee: |
Miles Laboratories, Inc.
(Elkhart, IN)
|
Family
ID: |
23994275 |
Appl.
No.: |
06/501,609 |
Filed: |
June 6, 1983 |
Current U.S.
Class: |
422/404; 312/209;
422/942; 435/805; 436/169 |
Current CPC
Class: |
B01L
3/5085 (20130101); G01N 31/22 (20130101); Y10S
435/805 (20130101) |
Current International
Class: |
B01L
3/00 (20060101); G01N 31/22 (20060101); G01N
021/01 (); G01N 031/22 (); B01L 009/00 () |
Field of
Search: |
;422/55,56,61,58,102,104
;312/209 ;206/.83,.84 ;435/300,805 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
1033714 |
|
Jun 1966 |
|
GB |
|
1535643 |
|
Dec 1978 |
|
GB |
|
2031583 |
|
Apr 1980 |
|
GB |
|
Primary Examiner: Richman; Barry S.
Assistant Examiner: Carrier; Joseph P.
Attorney, Agent or Firm: Coe; Roger N.
Claims
What is claimed is:
1. Apparatus for simultaneously making multiple analyses of liquid
fluid, which apparatus comprises in combination:
multiple, separate, dip-and-read reagent test devices, each
consisting essentially of one carrier matrix pad, having reagent
incorporated therein, attached to the upper surface of one end of
an elongated, flexible substrate, wherein each said carrier matrix
pad is raised to a height substantially above the surface of the
substrate to which said matrix pad is attached; and
reagent test device holding means for accurately positioning and
retaining said carrier matrix pads of the reagent test devices
immobile during analyses, said reagent test holding means
consisting essentially of a base member for retaining said reagent
test devices in parallel alignment, a separate top member
containing openings substantially identical in size, number and
configuration to the carrier matrix pads, hinge means for
interconnecting the base member and the top member wherein the
openings of said top member are in registry with each carrier
matrix pad of said reagent test devices such that the reagent pads
project into said openings so as to immobilize and isolate each
carrier matrix pad during the analysis of a liquid fluid and
substantially eliminate runover from occurring between adjacent
carrier matrix pads on the reagent test devices, wherein said
reagent test device holding means is constructed of a rigid,
cleanable material of thickness such that the openings in said top
member form wells into which liquid fluid to be analyzed is
placed.
2. The apparatus of claim 1 in which the reagent test device
holding means is plastic.
3. The apparatus of claim 1 in which the means for interconnecting
the base member and top member of said reagent test holding means
is a piano hinge.
4. Apparatus for simultaneously making multiple analyses of liquid
fluid, which apparatus comprises in combination: multiple,
separate, dip-and-read reagent test devices, each consisting
essentially of a plurality of carrier matrix pads having reagent
incorporated therein, attached to the upper surface of an
elongated, flexible substrate in a horizontally spaced manner,
wherein each said carrier matrix pad is raised to a height
substantially above the surface of the substrate to which said
matrix pad is attached; and reagent test device holding means for
accurately positioning and retaining said carrier matrix pads of
the reagent test devices immobile during analyses, said reagent
test holding means consisting essentially of a base member for
retaining said reagent test devices in parallel alignment, a
separate top member containing openings substantially identical in
size, number and configuration to the carrier matrix pads, hinge
means for interconnecting the base member and the top member
wherein the openings of said top member are in registry with each
carrier matrix pad of said reagent test devices such that the
reagent pads project into said openings so as to immobilize and
isolate each carrier matrix pad during the analysis of a liquid
fluid and substantially eleminate runover from occurring between
adjacent carrier matrix pads on the reagent test devices, wherein
said reagent test device holding means is constructed of a rigid,
cleanable material of thickness such that the openings in said top
member form wells into which liquid fluid to be analyzed is
placed.
5. The apparatus of claim 4 in which the reagent test device
holding means is plastic.
6. The apparatus of claim 4 in which the means for interconnecting
the base member and top member of said reagent test holding means
is a piano hinge.
Description
BACKGROUND OF THE INVENTION
1. Field Of The Invention
The present invention relates to apparatus for accurately
positioning and transporting multiple immunochemical, diagnostic or
serological test devices and, more particularly, to such apparatus
which facilitates automated processing of the test devices.
The art of analytical chemistry has been greatly advanced since
biochemistry began emerging as a primary scientific frontier,
requiring increasingly sophisticated analytical methods and tools
to solve problems. Likewise the medical profession has lent impetus
to the growth of analytical chemistry, with its desiderata of both
high precision and speed in obtaining results.
To satisfy the needs of the medical profession as well as other
expanding technologies, such as the brewing industry, chemical
manufacturing, etc., a myriad of analytical procedures,
compositions and apparatus have evolved, including the so called
"dip-and-read" type reagent test devices. Reagent test devices
enjoy wide use in many analytical applications, especially in the
chemical analysis of biological fluids, because of their relatively
low cost, ease of usability, and speed in obtaining results. In
medicine, for example, numerous physiological functions can be
monitored merely by dipping a reagent test device into a sample of
body fluid, such as urine or blood, and observing a detectable
response, such as a change in color or a change in the amount of
light reflected from or absorbed by the test device.
Many of the "dip-and-read" test devices for detecting body fluid
components are capable of making quantitative or at least
semiquantitative measurements. Thus, by measuring the response
after a predetermined time, an analyst can obtain not only a
positive indication of the presence of a particular constituent in
a test sample, but also an estimate of how much of the constitutent
is present. Such test devices provide the physician with a facile
diagnostic tool as well as the ability to gage the extent of
disease or of bodily malfunction.
Illustrative of such test devices currently in use are products
available from the Ames Division of Miles Laboratories, Inc. under
the trademarks CLINISTIX, MULTISTIX, KETOSTIX, N-MULTISTIX,
DIASTIX, DEXTROSTIX, and others. Immunochemical, diagnostic or
serological test devices such as these usually comprise one or more
carrier matrices, such as absorbent paper, having incorporated
therein a particular reagent or reactant system which manifests a
detectable response, e.g., a color change in the presence of a
specific test sample component or constituent. Depending on the
reactant system incorporated with a particular matrix, these test
devices can detect the presence of glucose, ketone bodies,
bilirubin, urobilinogen, occult blood, nitrite, and other
substances. A specific change in the intensity of color observed
within a specific time range after contacting the test device with
a sample is indicative of the presence of a particular constituent
and/or its concentration in the sample. Some of these test devices
and their reagent systems are set forth in U.S. Pat. Nos.
3,123,443; 3,212,855; 3,814,668; etc.
Regardless of whether the test device is used for the determination
of biological fluid or the analysis of a commercial or industrial
fluid, the normal procedure requires that each test device
separately come in contact with the sample or specimen to be tested
and then that the test device be visually or instrumentally
analyzed. Means has been sought in the art for accurately
positioning and retaining multiple individual test devices for
automated processing. Prior to the present invention no known
system had the capability of achieving the desiderata mentioned
above in which multiple, individual test devices could be retained
in apparatus for automatic processing without a change in format of
the test device.
2. Description Of The Prior Art
The traditional dip-and-read test device can be manufactured at
relatively low cost and it is convenient for an individual to use,
but it is not well suited for use with highly automated equipment.
For automated equipment to be of any advantage, it must result in a
benefit with respect to cost, handling, and/or speed of obtaining
information. Apparatus currently available for instrumentally
reading individual reagent strips, such as the SERALYZER
reflectance photometer or the CLINITEK reflectance photometer,
manufactured and sold by the Ames Division of Miles Laboratories,
Inc., Elkhart, Ind., requires that each reagent test device must be
manually loaded into the instrument after contacting the test
device with specimen or sample to be tested. Manual loading
requires that the reagent test device be properly positioned in the
instrument within a limited period of time after contacting the
solution or substance to be tested. At the end of the analysis,
each test device must be removed from the instrument for
disposal.
A different format is presently used in the CLINILAB automated
urinalysis system, which is manufactured and sold by the Ames
Division of Miles Laboratores, Inc., Elkhart, Ind. The CLINILAB
instrument uses a cassette containing reagent areas mounted
seriatim on a continuous plastic substrate which is wound into a
reel and housed in a cassette. While the CLINILAB reagent cassette
is well suited for automation, the manufacturing cost for this type
of format amounts to eight times that of the conventional
dip-and-read test device format mentioned above.
In accordance with the present invention instrumental testing for
immunochemical, diagnostic or serological purposes can be achieved
using multiple conventional dip-and-read type reagent test devices.
The apparatus results in an efficient, economical, rapid and
convenient way of performing such analyses.
SUMMARY OF THE INVENTION
An object of the present invention is to provide a rigid holder for
multiple reagent test devices.
Another object of the present invention is to provide a holder for
multiple reagent test devices which permits the accurate
positioning and transporting of such test devices in automated
equipment.
Still another object of the present invention is to provide
apparatus for conducting immunochemical, diagnostic or serological
tests employing multiple, conventional, low cost, visual,
dip-and-read reagent test devices.
In accordance with the present invention a holder for reagent test
devices is provided having a base member and a top member which
permit multiple individual reagent test devices to be accurately
positioned parallel to one another, said top member having openings
exposing each reagent area on the test devices for the application
of specimen or sample to be tested and the taking of reflectance
measurements.
BRIEF DESCRIPTION OF THE DRAWINGS
Other and further objects, advantages and features of the invention
will be apparent to those skilled in the art from the following
detailed description thereof, taken in conjunction with the
accompanying drawings, in which:
FIG. 1 is a top view of apparatus in accordance with the present
invention, said apparatus being open to receive individual reagent
test devices;
FIG. 2 is a perspective view of the apparatus of FIG. 1 in which
multiple reagent test devices have been inserted, the top member
being closed following the insertion of the test devices; and
FIG. 3 is a perspective view of another embodiment of the invention
designed to hold multiple, single pad reagent test devices.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
The apparatus forming the subject matter of the present invention
is characterized by a base member and top member which are or can
be interconnected in such a manner to permit the insertion of
multiple, individual reagent test devices into the apparatus such
that the test devices are aligned parallel to each other. When the
top member is closed reagent pads on the reagent test devices are
exposed through openings in the top member corresponding to the
location and dimension of the reagent pads on each test device.
While the top member and base member are preferably permanently
interconnected by hinge means in a fashion which permits the
apparatus to be opened and closed, the base member and top member
can, if desired, constitute separate members which become engaged
in suitable fashion once multiple test devices have been placed
onto or inserted into the base member.
Turning now to FIG. 1 of the drawings, reagent test device holder
10 of the present invention is shown in an open position with base
member 12 and top member 14 interconnected by means of flexible
plastic interconnecting member 16. The design of the apparatus
permits the entire assembly to be molded at one time. By having the
top member permanently interconnected to base member 12 there is
also the advantage that the top member cannot be misplaced or lost
when the apparatus is opened.
Reagent test device holder 10 can be constructed of any suitable
material such as polyethylene, polypropylene, ethylene copolymer,
polystyrene, phenolic polymer, polycarbonate,
acrylonitrile-butadiene-styrene copolymer, etc. Obviously, the
material should be chosen to be durable, readily cleanable and
relatively inexpensive. Aluminum or some other suitable metal could
also be used for this purpose although metal holders tend to be
somewhat more expensive than plastic holders. Another material
which could be used, although less preferable, is cardboard which
has been especially treated by a suitable coating to make it water
impermeable.
Base member 12 can have suitable ridges or other means which
facilitate proper alignment of reagent test devices to assure that
they become precisely parallel to one another. Top member 14, on
the other hand, is constructed to have openings 18--18 which are of
the same number and the same configuration as the reagent pads
appearing on each reagent test device placed in base member 12.
While the openings in the top member of the holder are preferably
of the same configuration as the reagent pads on the reagent test
device, these openings can be of any suitable configuration and, if
desired, can be circular rather than square or rectangular. Top
member 14 is designed to interconnect with base member 12 such that
after multiple reagent test devices have been inserted into holder
10 the top member can be connected with the base member to achieve
perfect registry between the openings 18--18 in top member 14 and
the reagent pads on the reagent test devices 20--20, as shown in
FIG. 2.
While the holders of the present invention can be made
inexpensively such that the entire holder is disposable, the design
of the holder apparatus facilitates the ready removal of used test
devices and the reutilization of the reagent holder. Normally, all
that is required in order to recondition a reagent holder device
for reuse is simply removing any excess fluid by suitable blotting
or through the use of controlled airflow. If desired, however, the
reagent holders can be thoroughly cleaned after each use.
While the illustrated reagent holders are more or less rectangular
in configuration, other suitable configurations can be used if
desired. For example, circular holders could be employed with the
reagent test devices radiating out from the center of the circular
holder. The preferred rectangular configuration, however, permits
the maximum number of reagent test devices to be inserted into a
holder of the smallest possible dimensions.
As previously indicated, base member 12 and top member 14 can be
interconnected by means 16. It will be understood, however, that
any suitable means of permanently or temporarily interconnecting
base member 12 and top member 14 can be used. For example, suitable
hinges include a piano type hinge or any other suitable connecting
hinge. Alternatively, base member 12 and top member 14 can be
entirely separate, becoming interconnected when the two pieces are
brought (snapped) together such that the members are aligned in a
particular manner in registry with the reagent matrices of the test
devices which have been inserted between the base member and the
top member.
While FIGS. 1 and 2 illustrate top member 14 containing ten
openings 18--18 for each reagent test device, the number of
openings can be varied depending upon a number of reagent pads
present on the reagent test devices employed. In FIG. 3, for
example, a holder for single pad reagent test devices is shown in
which the top member of the holder contains a single opening 22--22
for each reagent test device.
Whereas FIGS. 2 and 3 illustrate the handle portion of the reagent
test devices extending beyond the holder, it should be understood
that the reagent holder can be made long enough to accommodate the
entire reagent test device.
Once the reagent test devices have been inserted into the holder
the reagent pads, which are exposed by the openings in the top
member of the reagent holder, can be contacted with sample to be
tested by any suitable means. For example, the entire holder can be
dipped into the sample to be tested. Preferably, however, the
sample to be tested is applied to the pads by convenient means such
as placing one or more drops of the sample to be tested directly on
each reagent pad. The latter procedure, obviously, can be automated
using multiple dispenser tips interconnected to a common reservoir
containing sample to be tested.
Because of the configuration of the holder apparatus, multiple test
devices can be preloaded into each holder and individual or
multiple holders fed into automated photometric apparatus for
determining reflectance characteristics of treated reagent
pads.
From the foregoing, it will be seen that this invention is well
adapted to attain all of the ends and objects hereinabove set
forth, together with other advantages which are obvious and which
are inherent to the system. The apparatus of the present invention
has the advantages of convenience, simplicity, relatively
inexpensiveness, positiveness, effectiveness, durability, accuracy
and directness of action. The invention substantially overcomes the
problem of having to use different formats in order to facilitate
inexpensive, rapid, immunochemical, diagnostic or serological
testing. Conventional, low cost, visual type dip-and-read test
devices can be used. There is no need to adopt a different or more
expensive format. The holder apparatus of the present invention
provides a very effective way of accurately positioning and
transporting such test devices in automated instruments. Moreover,
the openings in the top of the holder, through which the reagent
pads are exposed, help prevent runover from occurring between
adjacent reagent pads on the test devices. Runover can be a serious
concern, particularly when incompatible reagents are present. Of
course, the holder permits rapid and accurate alignment of all of
the reagent pads in automated instruments upon alignment of the
reagent holder.
Another advantage of the reagent holder is that the holder protects
the reagent pads prior to use. This is a significant advantage in
that occasionally one or more of the reagent pad areas on a reagent
test device can become damaged during handling prior to or in the
process of using the test device due to the fact that the reagent
pad areas extend upward and are exposed on the surface of the test
device substrate.
Another advantage of the reagent holder is that it facilitates
contact of the reagent test devices with sample material and the
presentation of the sample contacted test device to an instrument
for performing a reflectance measurement thereby eliminating wasted
test devices which sometimes occur with inexperienced users who
have not developed a good technique for contacting specimen to be
tested with the reagent test device.
Should there be a desire to store test devices for any period of
time after testing, the holder of the present invention permits a
convenient way of storing and retaining such test devices.
Obviously, many other modifications and variations of the invention
as hereinbefore set forth can be made without departing from the
spirit and scope thereof.
* * * * *